http://www.starlakeporch.net/bbs/read.php?1,76743美国Beaumont医院临床试验的研究目的到底是什么？ (2540 bytes)
Posted by: babyfat
Date: March 05, 2011 02:03PM
【按：新语丝的羽矢等人断章取义，混淆视听，企图污蔑Beaumont医院在临床试验中故意设立一个简单的研究目的，藉以以蒙混过关，影响极坏，特澄清之，以正视听】
引用：[[url]http://xys.cnhub.net/bbs/read.php?id=797514[/url]]
他们的Primary Outcome Measures是Reproducible bladder contraction
送交者: 羽矢 于 2011-03-03 00:39:45:
回答: 谁知道他们定出的clinical significance是什麽吗？ 由 cornbug 于 2011-03-03 00:11:40:
引用：
[clinicaltrials.gov]
Primary Outcome Measures:
* Reproducible bladder contraction [ time frame: 6 to 24 months post procedure ] [ designated as safety issue: yes ]
The primary aim of this study is reproducible bladder contraction of 15cm/H20 or more with scratching the cutaneous dermatome and no significant contraction with stimulation of the non-operated side.
其实他们自己也搞不清楚，在一年结果论文中糊弄：
引用：
A difficult aspect of this study is how success should be defined.... Does the benefit of the procedure outweigh the inherent risks, particularly to the lower extremity? Is success defined as eliciting a detrusor contraction with stimulation of the dermatome? If this is the definition of success, then this surgery clearly works for the majority of patients.
引用：
[www.xys.org]
所有跟贴:
• He is trying to mislead - 猎人
o This as well as yours are typical examples of "clinical significance" - 猎人
o 他们那个7/9就是用的这个障眼法 - 羽矢
论文是另外一回事。NIH第一件事就要问什麽是 - cornbug
事实上，这个临床试验不仅有Primary Outcome Measures，也有Secondary Outcome Measures，后者涵盖了手术评估的方方面面。这些资料将被转交给同行，由他们来评价手术成功与否。
[clinicaltrials.gov]
Secondary Outcome Measures:
• Transfer of knowledge to other personnel to learn the procedure [ time frame: two years ] [ designated as safety issue: yes ]
Transfer of knowledge will be measured by comparing the following primary and secondary outcome measures across centers.
1. Global response assessment for voiding, defecation, and QOL
2. Percent voided/percent catheterized
3. Presence of detrusor sphincter dysynergia
4. Presence of urge incontinence
5. Presence of stress incontinence
6. Change in incontinence severity quantified by pad weights
7. Need for intermittent catheterization
8. Change in anal manometry
9. Change in bowel function
10. Change in quality of life
11. Goal Achievement
12. Adverse events